MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722003

Device Problem Overheating of Device (1437)

Patient Problem Radiation Overdose (1510)

Event Date 01/08/2017

Event Type  Injury  

Event Description

Philips received a complaint from the customer in which was stated that during an emergency procedure where a stent needed to be placed the x-ray system became overheated and the patient received 2.66 gy of air kerma.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: we conclude that the received dose of 2.66 gy is as expected when looking at the chosen settings and complexity of the performed procedure.Overheating of the x-ray tube was as expected due to the short amount of time between runs and did not influence the dose received by the patient.No correction on the system was needed since it is working within specification.When the tube becomes overheated the user is informed by a tube load indicator on the system, as this is mentioned in the instructions for use of the system.(philips allura xper fd series ¿ instruction for use -user interface document version 7.0, 9897 100 04071).

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 6266046
• MDR Text Key: 65358253
• Report Number: 3003768277-2017-00002
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 85